Determine if counselling patients on how to use Metered Dose Inhalers improves quality of life

ISRCTN	ISRCTN69215680
DOI	https://doi.org/10.1186/ISRCTN69215680
Protocol serial number	N0626168608
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Bradford South and West Primary Care Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Henry Chrystyn
Scientific

School of Pharmacy
University of Bradford
Bradford
BD7 1DP
United Kingdom

Phone	+44 (0)1274 233495
Email	h.chrystyn@bradford.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does an inhalation training aid designed for those using a Metered Dose Inhaler (MDI) maintain the correct inhalation technique after a patient has received training/counselling?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory: Asthma
Intervention	Patients will have their inhalation technique assessed whilst inhaling from a placebo inhaler. Those with a good technique will be placed in the control group. Those with a poor technique will form the intervention group. Subjects in the intervention group will be randomised into a group that receives verbal counselling on how to use their MDI and a group that also receives the verbal counselling with the addition of the Two Tone Training Aid.
Intervention type	Other
Primary outcome measure(s)	Changes in inspiratory flow rates through MDIs.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/03/2006

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	120
Key inclusion criteria	1. Asthma 2. Patients using at least one MDI without a spacer device Prescribed a preventer inhaler 3. Age 3-65 - Group 1: 3-6 years, Group 2: 7-17 years, Group 3: 16 to 65 years 4. Written signed consent
Key exclusion criteria	1. Patients experiencing an acute exacerbation of asthma or receiving oral prednisolone in the four weeks prior to recruitment 2. Patients with other illnesses adversely affecting the respiratory system or evidence of fixed respiratory obstruction 3. Deaf or unable to distinguish between one and two tones with the Two-Tone trainer 4. Chronic obstructive pulmonary disease (COPD)
Date of first enrolment	01/03/2005
Date of final enrolment	01/03/2006

School of Pharmacy

Bradford
BD7 1DP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2007		Yes	No